We considered the UX of frail individuals at this developmental, exploratory stage of a device to examine patient adherence and use. The UX assessment instrument adopted UX domains with a 5-point scale showing a more positive rating (rating of 5) and a lower rating (rating of 1). UX domains included device credibility, satisfaction, usability, adherence, effectiveness, relevance, and aesthetics. The primary outcome variable is patient compliance regarding wearing the device for 2 months. Additional data collected included the frequency of wearing the device during normal daily activities. Consistent with the literature, ADLs (such as ambulating and preparing meals) are critical for independence in aging populations [29].

Participants were recruited from among patients who were treated at our level 1 trauma center and subsequently admitted to the hospital for observation due to head injury. Protocol inclusion criteria included the following: patients admitted to the hospital with a fall sustaining a head injury, patients with fall risk (eg, patients who fell within the prior year or other physical conditions aligned with fall risk), and patients who were ambulatory and 55 years or older. Head injuries included in the study were patients with a concussion, contusion, lacerations, or loss of consciousness. The individuals recruited did not experience trauma that required surgical intervention. After signing the consent in the hospital, individuals were given an HPD at no cost to wear while ambulatory. After consenting and wearing the HPD for in-hospital observation (and just before discharge), the hospital team asked whether the patients would wear the HPD at home. If the patient agreed, we indicated that the research team would follow up post discharge for additional observations using the UX survey.

In total, 26 patients, who experienced a fall and sustained a head injury, wore an HPD in hospital, while ambulatory and were evaluated at baseline (before discharge) and at 2 months post discharge. The study protocol was approved by the institutional review board for research ethics and subsequently approved (IRB 1804935). Informed consent was obtained from the 26 patients who met the inclusion criteria and were willing to participate. Confidentiality of information was maintained. The data are anonymized and patients are deidentified. Each patient was assigned a discrete number in the study and data are secured by the research scientist. There was no compensation for patient participation in the study.

The HPD includes an impact-resistant technological insert for additional head protection. It helps protect against bumps, scrapes, bruises, and other head injuries. The HPD is designed with ventilation to provide airflow for breathability without compromised protection. The HPD size can be adjusted with a hook and loop strap to give a quick, secure fit. Figure 1 displays the HPD, which looks like a typical baseball cap.

A multidisciplinary health care team comprised of physicians, a research scientist, and physical therapists collaborated on the study design, developing a usability survey for patients who are at risk of fall, which led to a tangible and targeted intervention strategy. UX (usability) domain definitions were identified in the literature. Existing domain definitions were examined such as credibility, usability, and satisfaction [24], and additional domains were defined such as effectiveness, relevance, and aesthetics. The domains were refined, used on the usability survey instrument, and functioned as outcome measures. Textbox 1 shows the domains and UX definitions. UX domain data were collected on the instrument using a 5-point scale (5=strongly agree, 4=agree, 3=neutral, 2=disagree, and 1=strongly disagree). Patients were asked if they would recommend the HPD. The survey was intended to evaluate the HPD’s usability and was administered after patients concluded their interaction with the HDP in the hospital. Those who agreed to wear the HPD at home were provided a device and were reevaluated post discharge.

Quantitative data included demographics (age, sex, and race) and clinical data such as hospital LOS, number of GLFs, readmission to the hospital due to a GLF, and Glasgow Coma Scale. Data were also captured on the usability survey including domains such as device satisfaction, effectiveness, relevance, and aesthetics. Qualitative data were also collected on the usability survey, and patient comments were recorded regarding HPD benefits and opportunities for improvement.

This UX research methodology included multiple patient observations and differences between observations were examined. Nonparametric tests, used to analyze ordinal and categorical data, were used for intragroup comparisons (Wilcoxon signed rank test). We used descriptive statistics, such that patterns might emerge from the data. Frequencies and percentages are reported for categorical variables. Medians and means with SDs are reported for continuous variables as appropriate. All computations included 26 patients. Group comparisons were made using chi-square tests or Fisher exact tests, where numbers were small and were reported as numbers (%). All variables were assessed for normality. Analyses of categorical variables (age) and patient adherence were tested using the chi-square statistic. Statistical tests are 2-tailed, with a significance level of an α of .05. All statistical analyses were performed using SPSS Statistics for Windows (version 28.0; IBM Corp).

Open-ended patient comments (qualitative data) were analyzed using a 3-step process: data reduction, data display, and conclusion drawing and verification. Data reduction helped sort and compile data excerpts (to organize the data) and assist in developing assertions regarding patient perceptions surrounding wearability (eg, comfort and weight) and modifications of HPD, if necessary. Excerpts were annotated with topics such as the benefits of HPD: positive feedback (aspects recorded as positive by the patient participants regarding HPD experience and interaction) and negative feedback (points considered negative by the patients pertaining to interaction with the device). As a next step, we analyzed the themes that emerged and categorized them based on whether they were related to the usability of the HPD or the health support the device offered.

Among the 26 participants, 12 (46%) were female and 5 (19%) were non-White, with a median age of 77 (IQR 55-92) years. The average hospital LOS was 3.8 (SD 3.65) days. The majority (n=25, 96%) of patients who experienced head trauma were admitted to the hospital with a head injury due to a GLF (n=1, 4% were other types of falls); 22 (85%) had prior falls in the last 12 months and 16 (62%) had a hospital visit due to a head injury related to a fall within the year; 18 (69%) were on anticoagulants. The mean Glasgow Coma Score was 14.2 (SD 0.44). The age category was divided into 2 groups for analysis: age group 1 comprised of those who were 55 to 77 years and age group 2 comprised of patients 78 years and older.

In the hospital, all 26 consented patients wore the device with 0 falls recorded. After 2 months, 22 (85%) were wearing the HPD, had 0 falls, and had no hospital readmissions due to GLFs. At 6 months, 16 (62%) patients were compliant with wearing the device, with 0 falls and no hospital readmissions due to a GLF. The results showed positive scores, with no significant differences between ratings in hospital and post discharge regarding device credibility (0.42), satisfaction (0.60), usability (0.80), adherence (0.06), effectiveness (0.53), and relevance (0.09). A difference emerged for the domain of aesthetics. After the discharge, 8 (30%) patients had concerns regarding the device’s weight, saying it was slightly heavier than a typical cap. Overall, users had a positive experience with the HPD and scores revealed that patients felt it was effective and relevant. Thus, post discharge, users would recommend the HPD to others at risk for falls (mean 4.52, SD 0.51). Users were compliant by wearing the device in hospital and at 2 months post discharge, supporting the research hypothesis. Table 1 displays the UX domain means (SDs) for 2 observations.

Differences between categorical variables (age group 1: 55-77 years, group 2: 78 years and older, sex, and race) and protocol adherence were analyzed. Chi-square analysis showed differences in compliance regarding age (χ₁²=4.27; P=.04) but not sex (χ₁²=1.58; P=.23) or race (χ₁²=0.75; P=.60). Age group 1 was more likely to wear the device for normal daily activities.

The usability survey data captured patient device use during typical ADLs at 2 weeks and at 2 months post discharge. Users were provided a list of daily activities and were asked to rate the frequency of wearing the device. Consistent with the literature, ADLs, such as ambulating and preparing meals, are critical for independence in an aging population [29]. The highest score on the usability instrument was a “5” which indicated that the patient would wear the HPD “most often.” In-home contexts, patients indicated they most often wore the device ambulating and when driving (to meals and doctor appointments) and less often for personal hygiene. Table 2 shows within-group differences in device use in daily activities.

Open-ended questions on the usability instrument elicited patient qualitative comments regarding HPD benefits and opportunities for improvement. As a result, 2 dominant themes emerged, namely HPD usability and HPD as health support (protection). Usability was associated with the use of the device and functionality in terms of wearability. Health support included themes that were aligned with head protection for a patient.

Usability and relevance from the patients’ perspective translated into wearability, and the majority of patients wore the device after 2 months post discharge. Participants felt that the HPD was comfortable and easy to wear. However, 8 (30%) patients mentioned that the HPD was not as light as a typical cap due to the protective “technology insert” and suggested the HPD could be lighter in weight. One male participant stated,

Health support from the participant’s perspective sufficed as the primary benefit, as 18 (69%) commented that the device protected their head in the event of a fall. Patients called the device a “cap” as it resembles a baseball cap. One patient stated, “Protection for my head is important. I will wear it going out to eat and to doctor appointments.” Another female participant indicated, “I wear it eight hours a day to protect my head.” Two patients (male and female) indicated post discharge, they hit their heads on cabinets, as 1 commented:

A 74-year-old female participant stated, “I fell last year and I will wear this walking whenever possible. It protects my head.” A male participant noted, “The device is protective and comfortable; I forgot I had it on.” From patient comments, the HPD is cognate with head protection.

Using a UX design, we investigated the usability of a novel HPD on patients with head injury in acute care and home contexts to predict future compliance. All 26 patients provided positive scores for the HPD post discharge regarding satisfaction, usability, effectiveness, and relevance. Nonparametric tests showed positive results, with no significant differences between 2 observations at 2 months. Chi-square analysis showed a significant difference in HPD compliance regarding age but not sex or race as age group 1 was more likely to wear the device for normal daily activities. Patients most often wore the device ambulating and head protection was identified as the primary benefit. Thus, patients were most likely to recommend the HPD to others at risk of GLFs.

Due to the consistently high rate of head injuries after GLFs in our center, the targeted team strategy for an HPD and UX research design was developed. We realized that patient compliance in the geriatric population has been a limiting factor and approached that aspect first. Patients adhered to the research protocol by wearing the device in the hospital and post discharge, in the home, supporting the research hypothesis. At 2 months, 22 (85%) patients wore the device with 0 falls recorded and no readmissions due to falls.

Our multidisciplinary team, a diverse group of medical professionals, consisting of physicians, research scientists, and physical therapists, studied a device to be worn during daily activities in home environments. Recent literature has advocated for home care strategies [30] and interventions to be used in home contexts where falls most often occur [31]. Managing falls in this high-risk population is complex, requiring a systemic and collaborative approach directed by a multidisciplinary team focused on improving patient outcomes [3].

Accuracy is critical regarding the collection of patient data, and the in-hospital data collection was conducted under medical supervision. However, the limitations of the UX research included the nature of self-reporting by participants post discharge at 2 and 6 months. One measure to counter this bias was to include a family member during the evaluation to corroborate the patient’s self-reported data and responses. Another issue and limitation, we noted, was the difficulty of trying to reconnect or contact this population at follow-up due to cognitive decline, the extent and severity of head trauma, and other injuries associated with a GLF.

The results show our proposed HPD intervention will have a high compliance rate in those at risk for GLFs as it was considered usable, protective, and relevant. Managing individuals with fall risk may include future investigations of specific interventions and low-cost devices that preserve a patient’s independence and physical function, and research that contributes to further advancements in evidence-based treatment options. The feasibility and wearability of the device in patients with GLF with head injuries will inform future directions, which includes a multicenter study to evaluate compliance and device effectiveness. Our work will guide other health care institutions in pursuing cost-effective treatments and technological interventions that are usable and effective in improving outcomes for this fall risk population.